Sign Out
The recommended ULTOMIRIS maintenance dosing in adult and pediatric patients with PNH or aHUS with a body weight greater than or equal to 5 kg is based on the patient's body weight, as shown in Table 15, with maintenance doses administered every 4 or 8 weeks, starting 2 weeks after loading dose.
Refer to Table 16 for treatment initiation instructions in patients who are complement inhibitor treatment-naïve or switching treatment from SOLIRIS.
Dosing schedule is allowed to occasionally vary by ± 7 days of the scheduled infusion day (except for the first maintenance dose of ULTOMIRIS), but the subsequent dose should be administered according to the original schedule.
Adult patients with gMG with body weight greater than or equal 40 kg.
The recommended ULTOMIRIS maintenance dosing in adult patients with gMG with a body weight greater than or equal to 40 kg is based on the patient's body weight, as shown in Table 15, with maintenance doses administered every 8 weeks, starting 2 weeks after loading dose.
Refer to Table 16 for treatment initiation instructions in patients who are complement inhibitor treatment-naïve or switching treatment from SOLIRIS.
Dosing schedule is allowed to occasionally vary by ± 7 days of the scheduled infusion day (except for the first maintenance dose of ULTOMIRIS) but the subsequent dose should be administered according to the original schedule. (See Tables 15 and 16.)
Click on icon to see table/diagram/image
Click on icon to see table/diagram/imageSupplemental dosing following treatment with plasma exchange (PE), plasmapheresis (PP), or intravenous immunoglobulin (IVIg).
Plasma exchange (PE), plasmapheresis (PP), and intravenous immunoglobulin (IVIg) have been shown to reduce ULTOMIRIS serum levels. A supplemental dose of ULTOMIRIS is required in the setting of PE, PP, or IVIg (see Table 17).
Click on icon to see table/diagram/imageMethod of Administration: Intravenous (IV) Use: ULTOMIRIS is for administration by a healthcare provider and is not intended for subcutaneous administration.
This medicinal product must be administered through a 0.2 μm filter and should not be administered as an intravenous push or bolus injection.
For instructions on dilution of the medicinal product before administration, see Instruction for Use under Cautions for Usage.
ULTOMIRIS 100 mg/mL: ULTOMIRIS 100 mg/mL must be diluted to a final concentration of 50 mg/mL.
Following dilution, ULTOMIRIS 100 mg/mL is to be administered by intravenous infusion based on body weight as shown in Table 18 and Table 19. (See Tables 18 and 19.)
Click on icon to see table/diagram/image
Click on icon to see table/diagram/imageSpecial Populations: Women of Childbearing Potential: Women of childbearing potential should use effective contraception methods during treatment and up to 8 months after treatment.
Pediatric Population/Use in children: Use of ULTOMIRIS in pediatric patients for treatment of PNH is supported by evidence from a pediatric clinical study (13 patients aged 9 to 17 years). The safety and efficacy of ULTOMIRIS for the treatment of pediatric and adult patients with PNH appear similar. See Excipients/Inactive Ingredients under Description.
Use of ULTOMIRIS in pediatric patients for treatment of aHUS is supported by evidence from a pediatric clinical study (14 patients aged 10 months to 17 years). The safety and efficacy of ULTOMIRIS for the treatment of aHUS is consistent in pediatric and adult patients.
ULTOMIRIS has not been studied in PNH patients below 9 years of age. The posology to be used in pediatric patients with PNH is identical to the weight-based dosing recommendations provided for pediatric patients with aHUS, with maintenance dosing starting 2 weeks after loading dose administration. Based on the PK/PD data available in aHUS and PNH patients treated with ULTOMIRIS, this dosing regimen is expected to result in an efficacy and safety profile similar to that in adults, for all pediatric patients starting at 5 kg.
ULTOMIRIS has not been evaluated in pediatric patients with gMG.
Use in the Elderly: ULTOMIRIS may be administered to patients aged 65 years and over. There is no evidence indicating any special precautions are required for treating a geriatric population.
Patients with Aplastic Anemia: ULTOMIRIS may be administered to patients with PNH treated with concomitant medications for aplastic anemia (including immunosuppressive therapies). There is no evidence indicating any special precautions are required in patients with aplastic anemia.
Renal and Hepatic Impairment: Studies have not been conducted to examine the effects of hepatic impairment; however, pharmacokinetic data suggest that no dose adjustment is required in patients with hepatic impairment.
No dose adjustment is required for patients with renal impairment, see Pharmacology: Pharmacokinetics under Actions.
The clinical trials of ULTOMIRIS in patients with aHUS included patients with other complement-mediated TMA conditions (patients with renal impairment, some of whom were receiving dialysis). No dose adjustment is required in this population, see Pharmacology: Pharmacokinetics under Actions.
